REGULATORY AFFAIRS – REIMBURSEMENT
Martin Biggs Associates is a healthcare / regulatory affairs consultancy with over 30 years experience. We can provide advice and assistance with European, Australian, South African, Chinese and US – FDA authorization of drugs, devices, drug/device combinations, IUDs, and cosmetics.
- Drug / Medicinal Product registration in Europe and other territories
- CE marking / Medical Devices
- FDA Drug and Device registration
- Reimbursement of Drugs / Devices / Borderline Products / Food Supplements
- In vitro Diagnostics registration
- Stategic business planning and acquisitions
- Trademark searches and registration
- Patent and distributor searches
- Patenting – intellectual property management and marketing advice
- EU Cosmetics Directive
- Expert reports
- Advice as to choice of Notified Body and Competent Authority
- Advice on the most cost effective route to CE marking and the choice of Annex
- Selected List Scheme (SLS) and the Pharmaceutical Price Regulation Scheme (PPRS)
- Due diligence studies / risk analysis studies
- Authorized Representative services for Drugs, Devices, and Cosmetics
- Expert witness service
- Strategic marketing / pricing
- Are you having difficulty in obtaining listing of your product in the Drug Tariff?
- Do you need assistance with defending your brands against generic competition?
- Do you need advice on NICE cost-effectiveness reviews?
Consult us on a strictly confidential basis
Others do and have found our services profitable